BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAS INLINE VLV W/UNTZD CAT

    MDR report key: 3812475 · Received May 15, 2014

    Report

    Report Number
    1226348-2014-11636
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    February 15, 2012
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK112156
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECENTLY REVISED OUR MDR REPORTING PROCEDURES BASED ON FEEDBACK FROM A RECENT FDA AUDIT THAT WAS CONDUCTED IN 2013. ONCE THE CHANGES WERE MADE TO THE PROCEDURES, WE CONDUCTED RETROSPECTIVE REVIEW OF OUR PRODUCT COMPLAINTS AND MDR FILES. THE ATTACHED MDR REPORT IS BEING FILED AS RESULT OF THOSE CHANGES WE MADE TO OUR INTERNAL MDR REPORTING PROCEDURES. PLEASE REFER TO COMPLAINT COD (B)(4). AN INITIAL IS BEING GENERATED RECLASSIFYING THE EVENT AS A MALFUNCTION. IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED A REVIEW OF THE MANUFACTURING RECORDS HAVE BEEN CONDUCTED AND THEY REVEALED THAT THE DEVICE CONFORMED TO ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS PRIOR TO BEING RELEASED TO STOCK. IF AT SOME POINT THE DEVICE IS RETURNED FOR EVALUATION THIS COMPLAINT WILL BE RE-OPENED AND INVESTIGATED. BASED ON THIS EVALUATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REP REPORTED THAT THE PHYSICIANS ASSISTANT HAD TRIED 4 TIMES TO LOCATE/INDICATE THE VALVE AND KEPT GETTING 4 AND THIS PATIENTS CERTAS VALVE WAS SET ON 3. I CAME IN AND ASSISTED THE PA 4 MORE TIMES AND THE READING WAS STILL 4. THE PATIENT HAD SOME POST OP SWELLING SO LOCATING THE VALVE WAS A LITTLE MORE DIFFICULT. WE FINALLY LOCATED THE VALVE USING MY CERTAS NON STERILE SAMPLE AND THE LOCATOR TOOL. WE MARKED THE SWEET SPOT WITH A PEN AND FINALLY ON THE 9TH TRY GOT A INDICATION OF 3. THE PA WAS RELIEVED BUT VOICED HIS FRUSTRATION ON HAVING TO PALPATE THE VALVE AREA SO MANY TIMES AND PRESS THE LOCATOR TOOL ON THE SENSITIVE AREA IN ORDER TO LOCATE THE VALVE (THE PATIENT WAS IN PAIN SO THIS WAS A CONCERN). THE KEY FOR THE PA WAS HAVING A NON STERILE SAMPLE OF THE CERTAS VALVE TO ASSIST IN MARKING THE SPOT WHERE THE INDICATOR TOOL NEEDED TO BE TO GET THE PROPER SETTING. WE RECENTLY REVISED OUR MDR REPORTING PROCEDURES BASED ON FEEDBACK FROM A RECENT FDA AUDIT THAT WAS CONDUCTED IN 2013. ONCE THE CHANGES WERE MADE TO THE PROCEDURES, WE CONDUCTED RETROSPECTIVE REVIEW OF OUR PRODUCT COMPLAINTS AND MDR FILES. THE ATTACHED MDR REPORT IS BEING FILED AS RESULT OF THOSE CHANGES WE MADE TO OUR INTERNAL MDR REPORTING PROCEDURES. PLEASE REFER TO COMPLAINT COD (B)(4). AN INITIAL IS BEING GENERATED RECLASSIFYING THE EVENT AS A MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291694 CERTAS INLINE VLV W/UNTZD CAT SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. CMJCMC

    Patients

    Seq Age Sex Outcome Treatment
    1